Last reviewed · How we verify
Efficacy and Safety Study of Immunomodulator (Mycobacterium w) as an Adjunct Therapy in Category-II Pulmonary Tuberculosis Along With Assessment of Immunological Parameters
The purpose of the study is to study the efficacy and safety of Mycobacterium in treating patients with lung tuberculosis . Mycobacterium is a strain of bacterium which is used as a vaccine and an adjuvant drug against leprosy. This agent has also been found to be effective in the treatment of lung tuberculosis in a limited number of patients. The researchers are conducting this study in the World Health Organization (WHO) category-II of lung tuberculosis patients to see the efficacy and also to see any change in immunological parameters.
Details
| Lead sponsor | Ministry of Science and Technology, India |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1020 |
| Start date | 2005-03 |
| Completion | 2011-03 |
Conditions
- Tuberculosis
Interventions
- Intra-dermal administration of Mycobacterium w
Primary outcomes
- The time of sputum conversion as well as the early sputum conversion between the 2 groups will be evaluated. — from baseline (visit 2)
- The cure rate will be evaluated as the primary parameter of efficacy. — 8-9 months
- The relapse in patients of category II tuberculosis will be compared in both the groups. — at an interval of 6, 12, 18 and 24 months after the completion of the therapy
- Recording of any clinical adverse reactions at anytime during the study for assessment of safety — 2-8 weeks
Countries
India